Reported Dec 4, 2024 · Ongoing

dS Breast 16ch 3.0T

Philips North America LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

  • dS Breast 16ch 3.0T
Lot codes and dates
  • REF
    • 453530280731
    • 459801290741
    • 459801290741
    • 459801290744
    • 459801729891
    • 459801729892
  • UDI

    759 of 759 codes

    • 00884838065840
    • 00884838086197
    • 00884838098381
    • 00884838118041
    • Serial No. 538
    • 170
    • 437
    • 14
    • 124
    • 189
    • 291
    • 194
    • 516
    • 412
    • 154
    • 271
    • 536
    • 122
    • 190
    • 151
    • 1
    • 353
    • 577
    • 479
    • 446
    • 502
    • 522
    • 481
    • 583
    • 578
    • 608
    • 592
    • 160
    • 393
    • 421
    • 422
    • 438
    • 432
    • 540
    • 526
    • 470
    • 580
    • 477
    • 483
    • 586
    • 521
    • 133
    • 50
    • 440
    • 223
    • 461
    • 537
    • 517
    • 448
    • 550
    • 539
    • 573
    • 621
    • 628
    • 588
Amount recalled
5,231 units

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential safety issue where a patient may be harmed while preparing for or during a scan.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.